LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12€¦ · LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009 S. NO. DRUG NAME INDICATION APPROVA L DATE 1. Zoledronic Acid Injection

LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009

S. NO. DRUG NAME INDICATION APPROVA

L DATE

1. Zoledronic Acid Injection

5mg/100ml (Addl. Indication)

For the treatement of osteoporosis

in post-menopausal women and in

men who are at increased risk

offracture,including those with a

recent low-trauma hip fracture.

07.01.09

2. Misoprostol Tablet 600mcg Addl. Strength 09.01.09

3. Acebrophylline Syrup 10mg/ ml

For the treatement of adult patients

with chronic obstructive

pulmonarydisease(COPD) and

bronchial asthma.

09.01.09

4.

Selamectin Tropical solution

(forverterinary use.)

60mg/120mg per ml

(I) For the treatement and lasting

prevention of

fleainfestations,treatment and

control of flea allergy dermatitis,

prevention of

heartworm disease,treatement and

prevention of ear mites in dogs and

cats;

(II) For the treatement and

prevention

of sarcoptic mange,roundworms an

d for control of tick infestations in

dogs.

09.01.09

5.

Methylcobalamin1500mcg +

Calcium 200mg

+ Calcitriol 0.25mcg + Folic

Acid1.5mg + Pyridoxine3mg

Capsules

For the treatment of vitamin

deficiency states in adults 14.01.09

6. Metoprolol tartrate tablets 50 mg

(Addl. Indication) Adjunct to the treatement of

Hyperthyroidism 14.01.09

7. Cinacalet (as HCl) Tablet

30/60/90mg

For the treatment of secondary

hyperparathyroidism in patients

with chronic kidney diseases

(CKD) on dialysis and for

hypercalcemia in patients with

parathyroid carcinoma

14.01.09

8.

Mycophenolate mofetil Capsules

250mg, Tablets 500mg, Oral

suspension 200mg/ml (addl.

Indication)

For the prophylaxis of acute organ

rejection in

patients recievingallogenic hepatic

transplantation.

23.01.09

9.

Liquid Paraffin1.25ml + Milk of

Magnesia 3.75ml +

Sodium Picosulphate3.33mg per

5ml

For symptomatic treatment of

constipation in adults 29.01.09

10. Ranolazine 1000mg ER Tabs

(Additional Strength) Same as approved 31.01.09

11.

Hyaluronic acid (cross linked)

Pre-filled syringe 18mg/0.6ml

and 24mg/0.8ml

For intradermal implantation and

facial soft tissue augmentation 31.01.09

12. Caspofungin acetate Injection

(Addl. Indication)

For use in following: (I) Empirical

therapy for presumed fungal

infections in

febrile neutropenicpatients.

(II) Treatment of Candidemia and

the following Candida infections:

Intra-abdominal abscesses,

Peritonitis and Pleural space

infections.

(III) Treatment

of EsophagealCandidiasis.

(IV) Treatment of invasive

Aspergillosis in patients who are

refractory to or intolerant of other

therapies (i.e, amphotericin B, lipid

formulations of amphotericin B,

and/or itraconazole)

31.01.09

13.

Micafungin ( as sodium) Powder

for solution for infusion 50mg /

vial

For the treatment of patients

withcandidemia, acute disseminated

candidiasis, candida peritonitis,

abscess and esophageal candidiasis.

For the prophylaxis of Candida

infection in patients undergoing

hematopoietic stem cell

transplantation (HSCT)

31.01.09

14. Loteprednol Etabonate Nasal

spray 0.1% w/v

For prophylaxis and treatment of

the nasal symptoms of seasonal

allergic rhinitis. 31.01.09

15. Rasagiline (as mesylate ) Tablet

0.5mg/1mg

For the tratment of signs and

symptoms of idiopathic Parkinson's

disease as intial monotherapy and

as an addition to levodopa.

31.01.09

16. Nicotine Polacrilex Gum 2mg &

4mg (Addl. Indication)

To reduce the withdrawal

symptoms, including nicotine

craving, associated with quitting the

smoking and quitting chewed

tobacco and guthkacontaining

tobacco.

03.02.09

17. Closantel Injection100mg/ ml

(forverterinary use.)

For the infestation of trematodes,

nematodes, cestodes and arthropods

of domestic animals,

including milch and other food

producing animals.

05.02.09

18. Lornoxicam 4mg + Paracetamol

500mg film coated tablets

For the short term use in acute

painful & inflammatory conditions

in adults

05.02.09

19.

Cetrimide15% w/v +

Chlorhexidine Gluconate 7.5%

v/v + Isopropyl Alcohol 7.5%

v/v Concentrate Solution

For cleansing of physically

contaminated wounds and for pre-

operative disinfection 09.02.09

20.

Ketoconazole 2% w/v +

Prepared Coal Tar 2% w/v (I.P.

1966) Solution For the treatment of dandruff 09.02.09

21. Doripenem (as monohydrate)

Injection 250mg/500mg

For the treatment of nosocomial

pneumonia in adults. 16.02.09

22. Halobetasol Scalp Approved

0.05% w/v

For the relief of inflammatory

andpuritic manifestation of

corticosteroidrespensive dermatosis 18.02.09

23. Nicotine (as Polacrilex)

Lozenges 2mg & 4mg

To reduce the withdrawal

symptoms, including nicotine

craving, associated with quitting the

smoking and quitting chewed

tobacco and guthkacontaining

tobacco.

18.02.09

24. Tranexamic Acid Tab SR 750mg For the treatment of menorrhagia 20.02.09

25. Betahistine Mesilate Tablet

6mg/12mg

For the treatment of dizziness and

feeling of dizziness resulting from

Meniere's disease, Meniere's

syndrome and vertigo.

20.02.09

26. Abatacept Injection 250mg/vial

(Addl. Indication)

In moderately to severly active

rheumatoid arithritis in adults and

may be used as monotherapy or

concomitantly with DMARD's

other than TNF antagonists

20.02.09

27.

Anidulafungin Injection

(Lyophilized powder)

50mg/100mg per vial

For the treatment of invasive

candidiasis

including candidemia andesophage

al candidiasis in adult patients.

23.02.09

28.

Hydroquinone

2%+ Tretinoin 0.05% +

Hydrocortisone1%Cream

For the treatment of patients with

skin hyperpigmentation 23.02.09

29. Doxyphylline 400 mg +

Terbutaline 5mg tablets

For the treatment of asthma and

chronic obstructive pulmonary

disease in adult patients only

23.02.09

30.

Hydroquinone 20mg

+ Tretinoin 0.25mg +

Fluocinolone Acetonide 0.1mg

per gm Cream

For the treatment of melasma of

face in adults 23.02.09

31. Ketoconazole 2% +

Zinc Pyrithone 1% Lotion For the treatment of pityriasis and

dandruff of the scalp 23.02.09

32.

Lamivudine 30mg

+ Zidovudine 60mg

+Nevirapine 50mg Oral

Suspension (Tablets for oral

Suspension)

For the treatment of HIV patients 23.02.09

33.

Glibenclamide 5mg

+ Pioglitazone 15mg +

Metformin500mg film coated

tablets

As 3rd line treatment of type II

diabetes mellitus when diet,

exercise and the single agents and

the second line therapy with two

drugs do not result in

adequate glycemic control

23.02.09

34.

Aceclofenac 100mg

+ Tizanidine 2mg film coated

tablets

For the treatment of acute low back

pain in adult patients only 23.02.09

35.

Octinoxate 7.5%

+ Avobenzone 3% +

Oxybenzone 3% + Titanium

dioxide 2% lotion

As sunscreen lotion for prevention

of sunburn skin 23.02.09

36. Cetrizine 5/10mg

+ Ambroxol 30mg per 5ml syrup

For the symptomatic relief of

productive cough associated with

allergic rhinitis, when both anti-

histamine and mucolytic agents are

desired

23.02.09

37. Lidocaine Lozenges 200/300mg For single agent anesthesia in upper

gastro intestinal endoscopy. 26.02.09

38. Calamine 8% + Liquid

Paraffin10% lotion As antipruritic and smoothening

agent 26.02.09

39. Nifedipine 0.3% +

Lidocaine1.5% cream For the treatment of anal fissures 26.02.09

40. Quinapril 20mg + HCTZ 25mg

film coated tablet

For the treatment of mild to

moderate hypertension in adult

patients (in whom combination

therapy is appropriate) who have

been stabilized on the individual

components given in the same

proportion

26.02.09

41.

Levodopa 100/100/250

+ Carbidopa10/25/25mg mouth

dissolving tablet

For the symptomatic symptoms of

idiopathic Parkinson's Disease 04.03.09

42. Paliperidone ER Tablets 1.5mg Addl. Strength 04.03.09

43. Losartan 100mg+ HCTZ 25 mg

tablet Additional higher strength 16.03.09

44. Darunavir(as ethanolate) Tablet

300mg

For the treatment of human

immunodeficiency virus (HIV)

infection in antiretroviral treatment

experienced adult patients, such as

those patients with HIV-1 strains

resistant to more than one protease

inhibitor when co-administered

with 100mg ritonavir, and with

other antiretroviral agents.

19.03.09

45. Ropivacaine HCl Inj.2/5/7.5/10

mg

For the production of local or

regional anasthesia for surgery and

for acute pain management.

19.03.09

46.

Butaphosphan 100g + Methyl

Hydroxybenzoate 1gm +

Cyanocobalamin50 gm Oral

powder (Veterinary Drug)

As vitamin and phosphorous

supplement for

livestock, shirmp and fish. 19.03.09

47. Fluticasone furoate Nasal spray

27.5mcg per spray

For the treatment of symptoms of

allergic rhinitis. 19.03.09

48.

Octinoxate 7.5%

+ Avobenzone 2% +

Oxybenzone 3%

+ Octocrylene 3%+ Zinc Oxide

2% lotion

A sunscreen lotion for prevention

of sunburn skin 19.03.09

49.

Omeprazole 20/40mg + Sodium

Bicarbonate 600mg+

Magnesium Hydroxide 700mg

sachet

Additional Strength 19.03.09

50.

Ambroxol 30mg

+ Levo salbutamol

1mg+ Guiphenesin 50mg /5ml

syrup

For the symptomatic relief of

bronchospasm in bronchial asthma

& chronic bronchitis 19.03.09

51. Montelucast 4

mg+ Levocetrizine 2.5 mg tablet Additional lower paedriatric dose 19.03.09

52. Surgical Sealant To be indicated for use in sealing

suture lines along arterial and

venous reconstructions.

26.03.09

53.

Lidocaine Patch 700mg in

aqueous base. (50 mg per gram

adhesive)

For the relief of pain associated

with post-herpetic neuralgia. It

should be applied only to intact

skin.

26.03.09

54. Bimatoprost Opthalmic solution

0.03%

For the treatment of hypotrichosis

of the eyelashes by increasing their

growth including length, thickness

and darkness.

30.03.09

55.

Trabectedin powder for

concentrate for solution for

infusion 1 mg/ vial


advanced soft tissue sarcoma, after

failure

of anthracyclines andifosfamide, or

who are unsuited torecieve these

agents.

30.03.09

56. Acebrophylline Syrup 10mg/ml

(Additional Indication)

For the treatment of children (age

6to 12years) with chronic

obstructive

pulmonary disease(COPD) and

bronchial asthma.

30.03.09

57. Mesalamine PR Tablets 1.2gm For the induction of remission in

patients with active, mild to

moderate ulcerative colitis. 30.03.09

58. Mycophenolate Mofetil Tablets

750mg Additional Strength Same as approved 31.03.09

59. Ketorolac Tromethamine Gel

2%w/w For the treatment of muscle, joint

and post-traumatic stress. 31.03.09

60. Theophylline 400mg SR

+ Montelukast10mg Tablet For the treatment of patients with

bronchial asthma 31.03.09

61.

Hyaluronic Acid Sodium Salt

0.2 gm + Silver Sulfadiazine 1.0

gm/25 gm tube Hyaluronic Acid

Sodium Salt 50 mg + Silver

Sulfadiazine 1.0 gm/ 100 gm

gauze pads impregneted with

cream.

For the treatment of wound of

different etiology 31.03.09

62. Telmisartan 80mg + Amlodipine

5mg tablet Additional higher strength 31.03.09

63.

Hyaluronic Acid Sodium Salt

(i) Each 15gm tube

contains: HyaluronicAcid

Sodium Salt 0.2gm/100gm

(ii) Sterile Gauze Pads

impregnated with cream: Each

gauze pad

containsHyaluronic Acid

Sodium Salt 50/100mg

For the treatment of wound of

different etiology 31.03.09

64.

Abatacept Injection

250mg/vial (additional

indication)

For reducing signs and symptoms

of moderately to severly active

polyarticular juvenile idiopathic

arthritis/juvenile rheumatoid

arthritis in pediatric patients 6 years

of age and older who have had an

inadequate response to one or more

DMARD's such as MTX

10.04.09

65.

Cetrizine 10 mg + Ambroxol 75

mg SR Tablet

For symptomatic relief of

productive cough associated with

allergic rhinitis, when both anti-

histamine and mucolytic agents are

desired

13.04.2009

66.

Ciclesonide 200mcg

+ Formoterol 6mcg

+ Tiotropium 9mcg MDI

Indicated as third line treatment of

severe cases of COPD,

whenmonotherapy and second line

therapy with two drugs do not

respond adequately.

13.04.2009

67.

Each film coated bilayred tablet

contains: Metoprolol

25mg/50mg + Chlorthalidone

12.5mg

For the tretament of patients with

mild to modrate essential

hypertension

13.04.2009

68. Milnacipran 25/50mg

Caps (Addl. Indication)

For the management

of fibromylagia. 15.04.2009

69.

Lornoxicam SR 16mg Tabs For the symptomatic treatment of

pain and inflammation in patients

of osteoarthritis & rheumatoid

arthritis

25.04.2009

70.

Palonosetron Hcl 0.075mg

IV Inj (Addl. Strength) Same as approved 25.04.2009

71.

Each film coated bilayred tablet

contains: Metoprolol

25mg/50mg + Chlorthalidone

6.25 mg /12.5mg

Additional strength 25.04.2009

72.

Albendazole 400 mg +

Ivermectin 6 mg tablet

For the treatment of

intestinalhelminthes and

suppression

ofmicrofilaraemia especially with

bancrofti infections

25.04.2009

73.

Decitabine Lyophilized powder

for injection 50mg/20ml vial

For treatment of patients with

myelodysplastic syndromes (MDS)

including previously treated and

untreated, de novo and secondary

MDS of all French-American-

British subtypes(refractory anemia,

refractory anemia with ringed

sideroblasts, refractory anemia with

excess blasts,

refractory anemia with excess

blasts in transformation, and

chronic myelomonocytic leukemia)

and intermediate-1, intermediate-2,

and high-risk international

Prognostic Scoring System groups.

25.04.2009

74.

Retapamulin Ointment 1% For the topical treatment of

bacterial skin and skin structure

infections:-Primary impetigo,

secondarily infected traumatic

lesions, secondarily infected

dermatoses.

25.04.2009

75.

Each ml contains Calamine 15%

w/v + Zinc oxide 5% w/v +

Bentonite 3%

w/v+Glycerin 5%w/v + Sodium

citrate 0.05 % w/v lotion

For the tretament of pruritis and

prickly heat 08.05.2009

76.

Each 1000 ml of emulsion

contains: Medium chain

triglycerides 100 gm + Soya oil

80 gm + Omega-

3 acidtriglycerides 20 gm + egg

lecithin 12 gm + Glycerl 25 gm

+ Sodium oleate 0.30 gm +

Alpha -tocopherol 0.20 gm

+Ascorbypalmitate 0.30 gm +

Sodium hydroxide max. 0.06 gm

+ water for injection 784 gm

emulsion for infusion

For the supply of fats, including

essential omega-6 fatty acids and

omega-3 fatty acids, as part of a

parenteral nutrition regimen

in adults if oral or enteral nutrition

is impossible, inadequte or

contraindicated.

14.05.2009

77.

Sertaconazole Nitrate Powder

2% w/w & Lotion 2% w/v

For the topical treatment of the

superficial fungal infections of the

skin.

02.05.2009

78.

Amlodipine Tablets

5mg/10mg (additional

indication)

1. To reduce of fatal coronary heart

disease and non-fatal myocardial

infarction, and to reduce the risk of

stroke. 2. To

reduce the risk of coronary

revascularization procedures and

the need for hospitalization due to

angina in patients with coronary

artery disease.

02.05.2009

79.

Clindamycin Phosphate Inj.

150mg/ml &

Clindamycin HCl Capsules

150mg/300mg (additional

indication)

Prophylaxis of infection in neck

and head surgery 02.05.2009

80.

Each 15 gm sachet contains:

Lactulose 10 gm

+ Ispaghula husk 3.50 gm

granules

For the treatment of chronic

idiopathic constipation in adult

patients only

16.05.2009

81.

Sucralose for use as sweetner in drug

formulations 09.05.2009

82.

CarvedilolTablets 3.125/6.25/12.

5/25mg (additional indication)

To reduce cardiovascular mortality

in clinically stable patients who

have survived the acute phase of a

myocardial infarction and have a

left ventricular ejection fraction

of ≤ 40% (with or without

symptomatic heart failure)

09.05.2009

83.

Dexketoprofen 12.5 mg/25 mg +

Paracetamol 500 mg film coated

tablets

For the treatment of Acute

musculoskeletal pain 18.05.2009

84.

Pregabalin SR Tablet

150/300mg

For the treatment of peripheral

neuropathic pain in adults 16.05.2009

85.

Guaiphenesin ER Tablet

1200mg

For the treatment of productive

cough accompanied by Phlegm 16.05.2009

86.

Everolimus 5/10mg Tablets

(Addl. Indication)

Treatment of advance renal cell

carcinoma 16.05.2009

87.

Nimesulide ER 200mg

( Additional Indication)

Acute pain in Orthopaedic, ENT,

Dental and Post Operative

condition

16.05.2009

88.

Palonesetron Injection

0.25mg/5ml (Additional

Indication)

For treatment of Post Operative

Nausea & vomiting 16.05.2009

89.

Bendamustine Hydrochloride

Lyophilized powder Injection

100mg/ vial


chronic lymphocytic leukemia. 16.05.09

90.

Caffeine(as Citrate) 10mg /

ml Injection

For the short term treatment of

apnoea of prematurity of infants

between 28 and < 33 weeks

gestational age.

16.05.09

91.

Perindopril arginine

2.5mg/5mg/10mg film coated

tablet

For the treatment of arterial

hypertension, congestive heart

failure and coronary artery disease.

16.05.09

92.

Each gm

contains: Halobetasol 0.05%

w/w + Mupirocin 2.0 % w/w gel

For the topical treatment of

inflammatory dermatitis

withsecondry bacterial infection

16.05.09

93.

Mometasone 0.1 %

+ Fusidic acid 2%

cream/ointment

For the treatment of dermatoses

where secondry bacterial

and/orcandidial infection is present

25.04.09

94.

Thiocolchicoside 8 mg

+ Etoricoxib 60 mg tablets Additional strength 25.04.09

95.

Methadone Hydrochloride

5mg/10mg per ml syrup; 5mg/

10mg/ 20mg / 40mg tablet

For the treatment

of opioddependence and

in maintainencetreatment for opioid

dependence.

28.05.09

96.

Trospium Chloride film coated

tablet 20mg

For the treatment of overactive

bladder with the symptoms of urge

urinary incontinence, urgency, and

urinary frequency.

28.05.09

97.

Arformoterol (as Tartrate )

15mcg / 2ml Inhalation Solution

For the long term, twice daily

(morning and

evening) maintainencetreatment of

bronchoconstriction in patients with

chronic obstructive pulmonary

disease (COPD), including chronic

bronchitis and emphysema.

29.05.09

98.

Zolmitriptan...5.0%

w/v Benzalkonium Chloride

NF ... 0.01% w/v Nasal

spray

For the acute treatment of migraine

with or without aura in adults. 29.05.09

99.

Dexmedetomidine ( as HCl)

100mcg /ml Injection

For sedation of initially and

mechanically ventilated patients

during treatment in an intensive

care setting.

29.05.09

100.

Levetiracetam SR Tablet

500/750/1000mg same as approved

2.05.2009

101.

Glatiramer Acetate Injection

(20mg/ ml) & Pre-filled syringe

(20mg/ml)

For the reduction of the frequency

of relapses in patients with

Relapsing-Remitting Multiple

Sclerosis.

3.06.2009

102.

Yttrium-90 Microspheres

Injection (Yttrium-90...3GBq (at

the time of calibration) per vial)

For the treatment

of unresectablemetastatic

liver tumors from primary

colorectal cancer with intra-hepatic

artery chemotherapy (IHAC) of

FUDR (Floxuridine)

3.06.2009

103.

Luliconazole Cream 1%

For the treatment of cutaneous

mycosis viz. Tinea pedis, Tinea

corporis, Tinea cruris.

3.06.2009

104.

Magnesium Valporate Prolonged

release tablet 600mg

1) For the treatment

of generelized or partial seizures

as monothreapy or

adjunctive threapy. 2) For

prophylaxis of migraine headache

in adults. 3) For the treatment of

manic episodes associated with bi

polar disorders

4.06.2009

105.

Tenofovir Disoproxil Fumerate

300mg

For the treatment of chronic

Hepatitis B in adults

19.6.2009

106.

Bosentan (as monohydrate)

Tablets 62.5/125mg

For the treatment of pulmonary

arterial hypertension (WHO Group

I) in patients with WHO Class III or

IV symptoms, to

improve excerciseability and

decrease the rate of clinical

worsening.

23.6.2009

107.

Lornoxicam 12 mg SR

(additional strength)

same as approved 26.6.2009

108.

Azithromycin SR Granules for

oral suspension 2000mg

for the treatment for mild to

moderate susceptible infection

including RTI, uncomplicated skin/

skin structure, non gonococcal

urethritis, cervicitis

26.6.2009

109.

Metoprolol 50/50/25

mg + Atorvastatin20/10/10

mg + Ramipril 10/5/2.5 mg

capsules

As 2nd line treatment of patients

with both essential hypertension

and hypercholesterolemia who are

not adequately controlled by

combination of an anti-hypertensive

with lipid lowering agent.

1.07.2009

110.

Methyl Phenidate ER Tablet

10/20/30mg

For the treatment of Attention

Deficit Hyperactivity Disorder

(ADHD)

10.07.2009

111.

Dasatinib Tablets 100mg (addl.

Strength)


112.

Voglibose 0.2 mg + Metformin

500mg Tablets

As 2nd line treatment of type II

Diabetes mellitus when diet,

exercise and the single agent do not

result in adequate glycemic control.

13.7.2009

113.

Combipack of artesunate table

t and FDC Tablet

of sulphadoxine +

pyrimethamine

Composition:

A. combipack of 1 stip

of 3 tablets ofartesunate 25 mg

and 1 strip of 1 tablet

of sulphadoxine 125mg+

pyrimethamine 6.25

mg

B. combipack of 1 stip of 3

tablets ofartesunate 50 mg and 1

strip of 1 tablet


pyrimethamine 25

mg

C. combipack of 1 stip of 3

tablets ofartesunate 100 mg and

1 strip of 2 tablet


pyrimethamine 25

mg

D.combipack of 1 stip

of 3 tablets ofartesunate 200 mg

and 1 strip of 3 tablet


pyrimethamine 25 mg.

For the treatment of P. falciparum

resistant malaria patients

15.7.2009

114.

Milnacipran 100mg (additional

Strength)


115.

Rifaximin 400mg (additional

Indication)

For the treatment of hepatic

encephalopathy 18.7.2009

116.

Nevirapine tablet 50 mg for oral

suspension mg

For the treatment of HIV infection

in combination with other anti retro

viral agents

18.7.2009

117.

Desvenlafaxine (as Succinate)

ER Tablets 50mg/100mg

For the treatment of major

depressive disorder (MDD) 18.7.2009

118.

Posaconazole Oral Suspension

40mg/ml

For the treatment of oropharyngeal

candidiasis, including

oropharyngeal candidiasis

refractory

to itraconazoleand/orfluconazole.

For

prophylaxis of invasive Aspergillus

and Candida infections in patients,

13 years of age and older, who are

at high risk of developing these

infections due to

being severlyimmunocompromised,

such as hematopoietic stem cell

transplant (HSCT) recipients with

graft-versus-host disease (GVHD)

or those with hematologic

malignancies with prolonged

neutropenia from chemotherapy.

18.7.2009

119.

Caffeine Citrate 20mg / ml

(equivalent to 10mg of Caffeine

base) Oral Solution (Addl.

Dosage form)


120.

Amphotericin B Emulsion

5mg/ml (Addl. Indication)

Febrile Neutropenia in cancer

patients

18.7.2009

121.

Hydroxy ethyl starch 10%

Solution for infusion

For the treatment of imminent or

manifest hypovolemia and shock. 18.7.2009

122.

Naratriptan (as HCl) Tablets 1/

2.5mg

For the acute treatment of migraine

with or without aura in adults. 18.7.2009

123.

Colistimethate Sodium powder

for solution for

injection/infusion 500000IU and

2000000IU (additional Strength)


124.

Simvastatin 20 mg

+ Ramipril 5mg + Atenolol 50

mg + HCTZ 12.5 mg + Aspirin

100 mg (EC Pellets) Capsules

For secondary prevention

of coronoryheart disease/stroke in

patients where use of such

combination is appropriate

21.7.2009

125.

Colistimethate Sodium powder

for solution for inhalation

500000IU/1000000IU/2000000I

U

Treatment by inhalation of

Pseudomonas aeruginosa lung

infection in patients with cystic

fibrosis

28.7.2009

126.

Ramipril MR capsule 10mg For the treatment of hypertension/

cardiac failure and myocardial

infarction

30.7.2009

127.

Abacavir Sulfate Tablet 60mg For the treatment of HIV-1

infection in combination with other

antiretroviral agents

1.08.2009

128.

Zoledronic Acid Solution for

Infusion Addl. Indication

Prevention of clinical fractures after

hip fracture in men and women

1.08.2009

129. Sumatriptan 85 mg + Naproxen

500 mg Tablets

Additional Strength for the

treatment of migraine

3.08.2009

130.

Aceclofenac(100mg) +

Thiocolchicoside ( 8 mg) tablets

For the treatment of acute

inflammation conditions associated

with spasm in adults only

3.08.2009

131.

Aceclofenac(100mg) +

Thiocolchicoside ( 4 mg) tablets

(Additional strength)

For the treatment of acute

inflammation conditions associated

with spasm in adults only

11.08.2009

132.

Oxcarbazepine 150/300/600mg

Tablet (Addl. Indication

Treatment of generalized tonic-

clonic seizures in adults and

children

13.08.2009

133. Ofloxacin 2mg + Ornidazole 5

mg per ml Infusion

for the treatment of diarrhoea of

mixed infection in adult patients

17.08.2009

134. Clozapine Tablet200mg (Addl.

Strength)

Indicated in the management of

Schizophrenic patients

19.08.2009

135.

Oxymetazoline Hydrochloride

Nasal Spray50mcg/0.05%w/w

Is indicated for the relief of

stuffy,running nose associated with

colds and influenza, also post nasal

drip, sinusitis.

19.08.2009

136.

Enoxaparin Sodium Injection

(Addl.Indication)

Treatment of acute ST-segment

elevation myocardial infarction

including patients to be managed

medically or with subsequent

percuaneous coronary intervention

(PCI)

19.08.2009

137.

Fluvoxamine

Maleate100/150mg ER Tablets

For the treatment of obsessive

compulsive disorder (OCD)and

depression

19.08.2009

138.

Lidocaine Lozenges 200/300mg

(Addl. Indication)

For single agent anesthesia in

procedure involving the

introduction of instrument & tubes

into respiratory tract.

19.08.2009

139.

Risperidone long acting

injection (Addl. Indication)

Indicated as monotherapy or as

adjunctive therapy in lithium or

valproate for the maintenance

treatment of Bipolar-1 disorder.

29.08.2009

140

Exemestane 25mg Tablet (Addl.

Indication)

Indicated for adjuvant treatment of

Post Menopausal Women with

estrogen receptor positive early

breast cancer who have received

two-three year of tamoxifen and are

switched to exemestane for

completion of total of five years of

adjuvant hormonal therapy.

29.08.2009

141

Artesunate (25/50/100mg) +

Amodiaquine (67.5

mg/135/270mg) bilayerd Tablets

For the treatment of uncomplicated

malaria due to plasmodium

falciparum strain in various age

groups

01.09.2009

142 Ezetimibe 10 mg + Fenofibrate

145 mg Film coated tablets

For the treatment of combined

hyperlipidemia in patients with

normal hepatic and renal function

01.09.2009

143

Buprenorphine Transdermal

Patch Each Transdermal Patch

having an area of 6.25cm²,

12.5cm², and 25cm²contains:

Buprenorphine…5mg/10mg/20

mg having release rate of 5mcg,

10mcg, 20mcg Buprenorphine

per hour respectively(over a

period of 7 days).

For the treatment of severe opioid

responsive painconditions which

are not adequately responding to

non-opioid analgesics.For Hospital

supply only.

03.09.09

144 Trospium Chloride ER Capsules

60 mg

For the treatment of overactive

bladder with the symptoms of urge

urinary incontinence, urgency and

urinary frequency.

04.09.2009

145

Metoclopramide (as HCl)

200mg / 400mg per ml

Intranasal Solution

For the treatment of nausea and

vomiting.

09.09.09

146

Isosorbibe 20 mg + Hydralazine

37.5 mg tablets

For the treatment of heart failure as

an adjunct to standard therapy in

patients to improve survival, to

prolong time to hospitalization for

heart failure and to improve

patients reported functional status.

18.09.2009

147

Cefixime 200 mg + Dicloxacillin

ER 500 mg Tablets

For the treatment of adult patients

with Upper and Lower respiratory

tract infections, skin and soft tissue

infections

22.09.2009

148 Chlorthalidone Tablet

6.25mg For the treatment of mild to

moderate hypetension.

03.10.09

149

Cefovecin( as sodium) 80mg/

ml Lyophilised powder for

injection (Veterinary) For the treatment of skin bacterial

infections in dogs and cats.

03.10.09

150

Imidacloprid 10% + Moxidectin

1.0% & 2.5% Topical solution

(Veterinary) Each pippette

contains: (a)

0.4ml, 1.0ml, 2.5ml, 4ml of 10%

Imidacloprid and 1.0%

moxidectin (b) 0.4ml,

0.8ml of 10% Imidacloprid and

2.5% moxidectin

For the treatment and prevention of

flea infestations, prevention of

heartworm disease and treatment of

infections with gastrointestinal

nematodes in dogs and cats.

03.10.09

151

Isoflupredone

AcetateSuspension for Injection

(2mg per ml) ( For Veterinary)

For the glucocorticoid, anti-

inflammatory or supportive therapy

to cattle suffering from conditions

such as:

(1) Overwhelming infections with

severe

toxicity.

(2) Bovine ketosis.

(3) Musculoskeletal conditions.

(4) Shock.

(5) Parturient paresis (supportive

stress

therapy for milk fever).

03.10.09

152

Saxagliptin (as HCl) 2.5mg/

5mg Tablets

As an adjunct to diet and exercise

to improve glycemic control in

adults with type-2 diabetes

mellitus. (It should not be used for

the treatment of type 1 diabetes

mellitus or diabetic ketoacidosis, as

it would not be effective in these

settings.

24.10.09

153

Calcipotriol Gel

0.005% (additional

dosage form)

For the treatment of moderate

plaque psoriasis in adults

3.10.2009

154 Lamotrigine MR Tablets 150mg

(Addl. Strength) same as approved 3.10.2009

155

Metoprolol Tartrate ER Tablet

75mg

(additional strength)


156

Valganciclovir Powder for Oral

Solution 50mg/ml


cytomegalovirus (CMV) retinitis in

AIDS patients and for prevention of

CMV disease in solid organ

transplant patients at high risk

9.10.2009

157

Dexketoprofen Trometamol Gel

12.5mg/gm For the painful and inflammatory

conditions associated with joints,

tendons, ligaments and muscle

13.10.2009

158

Donepezil Hydrochloride

Orodispersible Tablet 5mg/10mg

For the treatment of mild to

moderate severe Alzheimer's

Dementia

15.10.2009

159

Dexketoprofen Trometamol

Injection 50mg/2ml

Symptomatic treatment of acute

pain of moderate to severe

intensity, when oral administration

is not appropriate such as post-

operative pain, renal colic and low

back pain.

22.10.2009

160

Bromocriptine Mesylate Tablet

IP 0.8mg, (additional Indication)

Indicated as an adjunct to diet and

exercise to improve glycemic

control in adults with type 2

diabetes mellitus.

22.10.2009

161 Levosulpride ER Tablet

100/150/200mg For the treatment of depression and

schizophrenia in adults

27.10.2009

162

Ambroxol 30 mg+ Terbutaline

2.5 mg + Guaiphenesin 100mg +

Menthol 2.5 mg per 5 ml syrup


163 Propofol 10 mg+ Lignocaine 2.5

mg per ml injection


164

Mecobalamin 750 mg +

Pyridoxine Hydrochloride1.5 mg

+ Nicotinamide 45 mg tablets

For the treatment of diabetic

neuropathy 27.10.2009

165

Olmesartan (20/40mg

)+ Atorvastatin 5/10/20mg film

coated tablets

For the treatment of co-existing

essential hypertension and

hyperlipidemia in adult patients

27.10.2009

166

Deltamethrin (0.50% m/v) and

Piperonyl Butoxide (2.0% m/v)

per ml Pour–On Solution

Ready to use pour-on for cattle,

sheep and goats.

1. For use in Cattle to control ticks,

stable flies, horn flies, cattle louse

flies and nuisance flies e.g. house

flies, to kill lice and protection

against blackflies.

2. For use in sheep and goats for

controlling Karoo paralysis, bont-

legged and red-legged ticks

29.10.2009

167

Glucosamine sulphate potassium

chloride 500 mg + Ibuprofen IP

200mg film coated Tablets

For the treatment of adult patients

with osteoarthritis of knee and/or

hip joints

03.11.2009

168

Methylcobalamin 1500 mcg +

Gabapentin SR 600 mg film

coated tablets


169 Propofol 1% for injection (Additional Indication)

1. For conscious sedation for surgical and

diagnostic procedures 2. for sedation of ventilated

patients receiving intensive care

5.11.2009

170 Rupatadine 10 mg + Montelukast 10 mg Tablets

For the management of seasonal

allergic rhinitis (SAR)

10.11.2009

171

Eperisone 50 mg + Paracetamol

500 mg Tablets

For improvement of mytonic

conditions caused by neck shoulder

arm syndrome , scapulhumeral

periarthritis and low back pain in

adult patients only

10.11.2009

172

Lafutidine Tablets

....5mg/10mg.

For the treatment of:

• gastric ulcers, duodenal ulcers and

stromal ulcers

• gastric mucosal lesions (erosion,

hemorrhage, redness or edema)

11.11.2009

associated with acute gastritis and

acute exacerbation of chronic

gastritis.

173

Ramosetron Hydrochloride

Tablets 2.5mcg, 5mcg, 0.1mg &

Injecton 0.3mg /2ml

1. Tablets 0.1mg & Injection 0.3--

for the prevention and treatment of

gastrointestinal symptoms (nausea

and vomiting) associated with

emetogenic cancer

chemotherapy.

2. Tablets 2.5mcg & 5mcg--- for

the treatment of diarrhoea

predominant irritable bowel

syndrome.

11.11.2009

174

Tadalafil tablet 20 mg


For the treatment of pulmonary

arterial hypertension

14.11.2009

175

Flurbiprofen Sodium 0.03%

Ophthalmic solution USP

for the reduction of post-operative

inflammatory condition

14.11.2009

176

Dexmedetomidine HCl Injection


Sedation of non-intubated patients

prior to and/or during surgical and

other procedure

14.11.2009

177

Paliperidone ER tablet 12 mg

(Additional Strength)

Same as approved 14.11.2009

178

1) Triticum Vulgare Topical

Cream Each 100gm of cream

contains:

Aqueous extract of Triticum

Vulgare (dry residue 200mg /

100ml) ..... 15gm

2-phenoxyethanol Eur.

Ph.....1gm

2) Triticum Vulgare Vaginal

Pessary Each 3.5gm of vaginal

pessary contains:

Aqueous extract of Triticum

Vulgare (dry residue 200mg/

100ml) .....0.60gm

2-phenoxyethanol Eur.

Ph.....0.04gm

1) Triticum Vulgare Cream is

indicated for the treatment of ulcers

and bed sores.

2) Triticum Vulgare Vaginal

Pessary is indicated for the

treatment of phlogistic and

dystrophic disorders of the female

genital tract.

14.11.2009

179

Febuxostat Tablets 80mg /

120mg

For treatment of chronic

hyperuricemia in conditions where

urate depression has already

occured (including a history, or

presence of tophus and /or gouty

arthritis).

14.11.2009

180

Euphorbia Prostrata Dry Extract

:100mg tablet (addl. Indication)

For the treatment of 3° and 4°

haemorrhoids (Addl. Indication).

14.11.2009

181

Euphorbia Prostrata dry extract

ethanolic 80%v/v[(35-70):1]

cream 1% w/w

For the treatment of 1° and 2°

internal haemorrhoids.

14.11.2009

182

Lactobacillus Rhammnosus 1

billion cells + Saccharomyces

Boulardi 125 mg + Zinc

Enriched yeast 20 mg sachets &

capsules

For the treatment of acute diarrhoea

in children

4.11.2009

183

Nimesulide 1.0% w/w + Ethanol

31% w/w topical solution

For the local application in

relieving pain in acute low

backache, tendonitis, tenosinovitis

and sprains

17.11.2009

184

Diacerein Modified Release

Capsule 100mg

Symptomatic treatment of

osteoarthritis of knee & hip

20.11.2009

185

Amlodipine

5mg/10mg/5mg/10mg/10mg +

Valsartan

160mg/160mg/160mg/160mg/32

0mg + Hydrochlorothizide

12.5mg/12.5mg/25mg/25mg/25

mg Tablets

For the treatment of essential

hypertension

24.11.2009

186

Maraviroc Tablets

150mg/300mg.

For the treatment of patients

infected with CCR5- trophic HIV-

1.

25.11.2009

187

S (+) Etodolac 150/200/300mg +

Paracetamol 500/500/500mg

Tablets

For the symptomatic treatment of

acute pain and inflammation in

patients with osteoarthritis,

rheumatoid arthritis and ankylosing

spondylitis

25.11.2009

188

Tacrolimus Granules for oral

suspension 0.2/1 mg per sachet

Prophylaxis of transplant rejection

in kidney, liver or heart allograft

recipient

26.11.2009

189

Rifaximin Dispersible Tablet

200mg

For infections diarrhoea in adults 26.11.2009

190

Prednisolone Sodium Phosphate

Orally Disintegrating Tablet

10/15/30mg

Indicating for condition required

Glucocorticoids activity including

collagen disease, allergic disease

and hypersensitive reaction

26.11.2009

191

Cinitapride Hydrogen Tartrate

ER Tablet 3mg


gastroesophageal reflux disease

(GERD) and functional

inconveniences of the

26.11.2009

gastrointestinal motility

192

Sevelamer Carbonate


for control of serum phosphorus in

patients with chronic kidney

disease on haemodialysis or

peritoneal dialysis and patients with

CKD not on dialysis with serum

phosphate > 5.5 mg/dl

26.11.2009

193

Oxcarbazepine Tablets

(Additional

Indication)150/300/600 mg

Monotherapy in the treatment of

partial seizures in children ages 4-

16

26.11.2009

194

Ketoprofen plaster 30 mg (7cm

X 10 cm)

for the relief of musculoskeletal

pain & inflammation

11.12.2009

195

Acipimox Capsules 250mg. As adjunctive therapy to diet and

weight loss in the treatment of type

IIa, IIb and IV lipid disorders.

26.11.2009

196

Amisulpiride SR Tablet 100 mg Same as approved 27.11.2009

197

Mycophenolate Sodium Enteric

coated tablet 540 mg (Additional

Strength)

Same as approved 29.10.2009

198

Loteprednol etabonate 0.5% w/v

+ Moxifloxacin 0.5% w/v

opthalmic Suspension

For the treatement of post operative

steriod responsive inflammatory

ocular infections or risk of bacterial

ocular infections exists

1.12.2009

199

Ropinirole ER tablet 2/4/8mg for the treatment of signs &

symptoms of idiopathic Parkinson's

disease

3.12.2009

200

Diclofenac Diethyl amine

transdermal patch 100 mg/37.5

sq cm (Additional Strength)


201

Lornoxicam ER Tablet 8 mg

(Additional Strength)


202

Flurbiprofen plaster 20 mg (7cm

X 10cm)

for the relief of pain &

inflammation due to rheumatoid

arthritis , osteoarthritis and allied

disorder

11.12.2009

203

Carvedilol Phosphate ER tablet

10/20/40/80mg

1. Mild to severe chronic heart

failure. 2. Left ventricular

dysfunction following myocardial

infarction in clinically stable

patients 3. hypertension

11.12.2009

204

Halometasone

monohydrate 0.05% w/w +

Fusidic acid 2.00% w/w cream

For the treatment of acute and

chronic infected eczematous

dermatitis

15.12.2009

205

Glimepiride 1/2 mg + Metformin

500 mg + Atorvastatin 10 mg

tablets

For the treatment of type II diabetes

mellitus associated with

dyslipidemia

17.12.2009

206

Betahistine Di hydrochloride CR

capsule 24/32/48mg

indicated in the treatment of

Menier's syndrome, characterized

by unilateral or bilateral tinnitus,

vertigo, sensorineural hearing loss

17.12.2009

207

Gefitinib tab 250mg (Additional

Indication)

Indicated for the first line treatment

of patients with locally advanced or

metastatic non small cell lung

cancer (NSLC) who have activating

mutationof the EGFRTK".

18.12.2009

208

Midazolam Hcl Syrup 2mg/ml For selection,anxiolysis and

amnesia prior to diagnostic,

therapeutic or endoscopic

procedure or before induction of

anesthesia.

18.12.2009

209

Guaiphenasin Syrup 133mg/5ml For the treatment of productive

cough accompanied by phlegm

18.12.2009

210

Balofloxacin Tablet 100mg for the treatment of uncomplicated

urinary tract infectins (such as

cystitis and urethritis)

22.12.2009

211

Xylometazoline 0.5 mg +

Ipratropium 0.6 mg Nasal spray

For symptomatic treatment of nasal

congestion with running nose

(rhinorrhea)

23.12.2009

212

Doxofylline 400 mg + Ambroxol

30 mg Tablets


bronchial asthma and COPD, when

use of both the drug is appropriate

23.12.2009

213

Ribavirin Capsules 200mg

(Addl. Strength)

Indicated in combination with peg

interferon alpha-2b for the

treatment of naïve adult patients

with chronic hepatitis C with

clinically stable HIV co-infection.

24.12.2009

214

Formoterol 6 mcg +

Mometasone furoate

100/200/400mcg Metered dose

Inhaler & Dry Powder Inhalation


bronchial asthma and COPD, where

the use of combination is found

appropriate

30.12.2009

215

Chlorohexidine Gluconate Gel

0.2%

For the prevention of Plaque and

treatment of gengivitis.

30.12.2009

216

Chlorohexidine Gluconate

Mouth wash 0.1%

For the prevention of Plaque and

treatment of gengivitis.

30.12.2009

217

Levodropropizine Eur. Ph. 30mg +

Chlorpheniramine maleate IP 2mg

per 5 ml Syrup

For the treatment of non-productive

cough 06.07.09

Documents

LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12€¦ · LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009 S. NO. DRUG NAME INDICATION APPROVA L DATE 1. Zoledronic Acid Injection